DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art reli1ed upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Thakur et al. (hereinafter ‘Thakur’, U.S. PGPub No. 2020/0178850).
In regards to claim 1, Thakur discloses a medical-device system for detecting and managing heart failure, the medical-device system comprising: a data receiver circuit configured to receive heart sound information sensed from a patient, the heart sound information including one or more of S1, S2, S3, or S4 heart sound components ([0042]: "FIG. 1 illustrates an example relationship 100 between physiologic information, including heart sounds 102 (first, second, third, and fourth heart sounds (S1, S2, S3, and S4))…"), and a heart failure detector circuit configured to generate a heart sound metric using the received heart sound information ([0079]: "The risk stratification circuit can generate a composite risk index indicative of the probability of the patient later developing an event of worsening of HF (e.g., an HF decompensation event) such as using the selected patient-specific sensor signals or signal metrics."), and generate a heart failure indicator indicating whether the patient has a heart failure with preserved ejection fraction (HFpEF) or a heart failure with reduced ejection fraction (HFrEF) based at least in part on the generated heart sound metric ([0034]: "FIG. 7 illustrates an example method including determining an indication of heart failure with preserved ejection fraction (HFpEF) of a subject using a determined change in cardiac acceleration information of the subject.").
In regards to claim 2, Thakur discloses a wearable device that includes an accelerometer and the heart failure detector circuit, the accelerometer configured to sense the heart sound information from the patient ([0069]: " In other examples, the wearable medical device 603 can include an acoustic sensor or accelerometer to detect acoustic information (e.g., heart sounds) or the sound or vibration of blood flow, an impedance sensor to detect impedance variations associated with changes in blood flow or volume, a temperature sensor to detect temperature variation associated with blood flow, a laser Doppler vibrometer or other pressure, strain, or physical sensor to detect physical variations associated with blood flow, etc.").
In regards to claim 3, Thakur discloses that the heart sound metric includes an S3 intensity metric, wherein the heart failure detector circuit configured to generate the heart failure indicator indicating a presence of HFpEF when the S3 intensity metric exceeds an S3 threshold ([0049]: "HFpEF can be detected using an increase in an E-wave measure or the combination of increases in E-wave and S3 measures during or immediately following exertion.").
In regards to claim 4, Thakur discloses that the data receiver circuit is configured to receive the heart sound information sensed from the patient when the patient is in a specific posture or engaged in a specific physical activity ([0054]: "In an example, the AMD can include one or more of...a posture sensor configured to receive posture or position information; a pressure sensor configured to receive pressure information; a plethysmograph sensor (e.g., a photoplethysmography sensor, etc.); or one or more other sensors configured to receive physiologic information of the subject.").
In regards to claim 5, Thakur discloses a posture sensor configured to detect the specific posture in the patient, or an activity sensor configured to detect the patient engagement in the specific physical activity ([0054]: "In an example, the AMD can include one or more of...a posture sensor configured to receive posture or position information…").
In regards to claim 6, Thakur discloses that the received heart sound information includes first heart sound information when the patient is in a resting state and second heart sound information when the patient in a physically active state, wherein the heart failure detector circuit is configured to: generate a first S3 intensity metric from the first heart sound information and a second S3 intensity metric from the second heart sound information ([0040]: "Exertion can be detected using activity or posture information. Changes in S3 with exertion, at elevated levels of activity, or following elevated levels of activity or a transition from a first level of activity to a second lower level of activity, may increase sensitivity or specificity of HFpEF detection, or enable HFpEF detection in existing systems previously not able to detect such conditions.") and generate the heart failure indicator indicating a presence of HFpEF based at least in part on a change or a rate of change from the first S3 intensity metric to the second S3 intensity metric ([0049]: "HFpEF can be detected using an increase in an E-wave measure or the combination of increases in E-wave and S3 measures during or immediately following exertion.").
In regards to claim 7, Thakur discloses that the heart sound metric includes an S1 timing relative to a fiducial point, the S1 timing indicative of a pre-ejection period, wherein the heart failure detector circuit is configured to generate the heart failure indicator indicating (i) a presence of HFrEF in response to the S1 timing relative to the fiducial point exceeding a threshold, and (ii) a presence of HFpEF in response to the S1 timing relative to the fiducial point falling below the threshold ([0088]: "At 708, an indication of HFpEF is determined, such as by the assessment circuit, using the determined change in cardiac acceleration information at exertion relative to rest, such as by comparing the determined change or a trend of the determined change to a threshold (e.g., an HFpEF threshold). ").
In regards to claim 8, Thakur discloses that the data receiver circuit is further configured to receive cardiac electrical activity information, wherein the heart failure detector circuit is configured to recognize, from the received cardiac electrical activity information, the fiducial point using a QRS complex within a cardiac cycle preceding the S1 component ([0054]: "...a cardiac sensor configured to receive cardiac electrical information…").
In regards to claim 9, Thakur discloses that the heart sound metric includes a heart sound-based systolic time interval between a QRS complex in a cardiac electrical signal and an S2 heart sound component with a cardiac cycle, wherein the heart failure detector circuit is configured to generate the heart failure indicator indicating (i) a presence of HFrEF in response to the heart sound-based systolic time interval falling below a threshold, and (ii) a presence of HFpEF in response to the heart sound-based systolic time interval exceeding the threshold ([0045]: "Systolic time intervals, such as pre-ejection period (PEP) or left ventricular ejection time (LVET) can be indicative of clinically relevant information, including contractility, arrhythmia, Q-T prolongation (with electrogram (EGM) information), etc. The PEP can be measured from a Q wave of an EGM to the time of the aortic valve opening, T2 in FIG. 1.").
In regards to claim 10, Thakur discloses that the heart sound metric includes an S1 to S2 time interval indicative of a left ventricular ejection time, wherein the heart failure detector circuit is configured to generate the heart failure indicator indicating (i) a presence of HFrEF in response to the S1 to S2 time interval falling below a threshold, and (ii) a presence of HFpEF in response to the S1 to S2 time interval exceeding the threshold ([0045]: "Systolic time intervals, such as pre-ejection period (PEP) or left ventricular ejection time (LVET) can be indicative of clinically relevant information, including contractility, arrhythmia, Q-T prolongation (with electrogram (EGM) information), etc. The PEP can be measured from a Q wave of an EGM to the time of the aortic valve opening, T2 in FIG. 1.").
In regards to claim 11, Thakur discloses that the heart sound metric includes a heart sound-based diastolic time interval between S2 and a subsequent QRS complex in a cardiac electrical signal, wherein the heart failure detector circuit is configured to generate the heart failure indicator indicating (i) a presence of HFrEF in response to the heart sound-based diastolic time interval falling below a threshold, and (ii) a presence of HFpEF in response to the heart sound-based diastolic time interval exceeding the threshold ([0047]: "The E-wave provides information about left atrial (LA) pressure in early diastole and occurs immediately following the isovolumetric relaxation time (IVRT) and mitral valve opening. ", [0051]: "FIG. 4 illustrates LV end-diastolic pressure (LVEDP) information 400 at rest and at exercise for patients with NCD 402 and for patients with HFpEF 404.").
In regards to claim 12, Thakur discloses that the heart failure detector circuit is configured to generate a trend of the heart sound metric over time, and to detect an indicator of HFpEF to HFrEF transition based at least in part on the trended heart sound metric ([0064]: "The assessment circuit 504 can be configured to provide an output to a user, such as to a display or one or more other user interface, the output including a score, a trend, an alert, or other indication.", [0088]: "At 708, an indication of HFpEF is determined, such as by the assessment circuit, using the determined change in cardiac acceleration information at exertion relative to rest, such as by comparing the determined change or a trend of the determined change to a threshold (e.g., an HFpEF threshold).").
In regards to claim 13, Thakur discloses a therapy circuit configured to initiate or adjust a heart failure therapy in response to the detected indicator of HFpEF to HFrEF transition ([0068]: "The IMD 602 can include an assessment circuit configured to detect or determine specific physiologic information of the subject 601, or to determine one or more conditions or provide information or an alert to a user, such as the subject 601 (e.g., a patient), a clinician, or one or more other caregivers. The IMD 602 can alternatively or additionally be configured as a therapeutic device configured to treat one or more medical conditions of the subject 601. The therapy can be delivered to the subject 601 via the lead system and associated electrodes or using one or more other delivery mechanisms.").
In regards to claim 14, Thakur discloses A method of detecting and managing heart failure using a medical-device system, the method comprising: receiving heart sound information sensed from a patient, the heart sound information including one or more of S1, S2, S3, or S4 heart sound components ([0042]: "FIG. 1 illustrates an example relationship 100 between physiologic information, including heart sounds 102 (first, second, third, and fourth heart sounds (S1, S2, S3, and S4))…"), generating a heart sound metric using the received heart sound information ([0079]: "The risk stratification circuit can generate a composite risk index indicative of the probability of the patient later developing an event of worsening of HF (e.g., an HF decompensation event) such as using the selected patient-specific sensor signals or signal metrics."), and generating a heart failure indicator indicating whether the patient has a heart failure with preserved ejection fraction (HFpEF) or a heart failure with reduced ejection fraction (HFrEF) based at least in part on the generated heart sound metric ([0034]: "FIG. 7 illustrates an example method including determining an indication of heart failure with preserved ejection fraction (HFpEF) of a subject using a determined change in cardiac acceleration information of the subject.").
In regards to claim 15, Thakur discloses that the heart sound metric includes an S3 intensity metric, wherein generating the heart failure indicator includes an indicator indicating a presence of HFpEF when the S3 intensity metric exceeds an S3 threshold ([0049]: "HFpEF can be detected using an increase in an E-wave measure or the combination of increases in E-wave and S3 measures during or immediately following exertion.").
In regards to claim 16, Thakur discloses sensing a posture or a physical activity state of the patient using an ambulatory sensor ([0054]: "In an example, the AMD can include one or more of...a posture sensor configured to receive posture or position information…") and sensing the heart sound information using an accelerometer when the sensed posture or the sensed physical activity satisfies a condition ([0069]: " In other examples, the wearable medical device 603 can include an acoustic sensor or accelerometer to detect acoustic information (e.g., heart sounds) or the sound or vibration of blood flow, an impedance sensor to detect impedance variations associated with changes in blood flow or volume, a temperature sensor to detect temperature variation associated with blood flow, a laser Doppler vibrometer or other pressure, strain, or physical sensor to detect physical variations associated with blood flow, etc.").
In regards to claim 17, Thakur discloses that sensing the heart sound information includes sensing first heart sound information when the patient is in a resting state and sensing second heart sound information when the patient in a physically active state, wherein generating the heart sound metric includes generating a first heart sound metric from the first heart sound information and a second heart sound metric from the second heart sound information, wherein generating the heart failure indicator is based at least in part on a change or a rate of change from the first heart sound metric to the second heart sound metric ([0040]: "Exertion can be detected using activity or posture information. Changes in S3 with exertion, at elevated levels of activity, or following elevated levels of activity or a transition from a first level of activity to a second lower level of activity, may increase sensitivity or specificity of HFpEF detection, or enable HFpEF detection in existing systems previously not able to detect such conditions.").
In regards to claim 18, Thakur discloses that the first heart sound metric includes a first S3 intensity metric when the patient is in the resting state, and the second heart sound metric includes a second S3 intensity metric when the patient in the physically active state, wherein generating the heart failure indicator includes an indicator indicating a presence of HFpEF in response to a difference between the first and the second S3 intensity metrics exceeding a threshold ([0049]: "HFpEF can be detected using an increase in an E-wave measure or the combination of increases in E-wave and S3 measures during or immediately following exertion.").
In regards to claim 19, Thakur discloses that the heart sound metric includes a cardiac timing interval representing at least one of a pre-ejection period, a systolic time interval, a left ventricular ejection time, or diastolic time interval, wherein generating the heart failure indicator includes an indicator indicating a presence of HFpEF or a presence of HFrEF based on a comparison of the cardiac timing interval to a threshold ([0045]: "Systolic time intervals, such as pre-ejection period (PEP) or left ventricular ejection time (LVET) can be indicative of clinically relevant information, including contractility, arrhythmia, Q-T prolongation (with electrogram (EGM) information), etc. The PEP can be measured from a Q wave of an EGM to the time of the aortic valve opening, T2 in FIG. 1.", [0047]: "The E-wave provides information about left atrial (LA) pressure in early diastole and occurs immediately following the isovolumetric relaxation time (IVRT) and mitral valve opening. ", [0051]: "FIG. 4 illustrates LV end-diastolic pressure (LVEDP) information 400 at rest and at exercise for patients with NCD 402 and for patients with HFpEF 404.").
In regards to claim 20, Thakur discloses detecting an indicator of HFpEF to HFrEF transition based at least in part on a trend of the heart sound metric ([0064]: "The assessment circuit 504 can be configured to provide an output to a user, such as to a display or one or more other user interface, the output including a score, a trend, an alert, or other indication.", [0088]: "At 708, an indication of HFpEF is determined, such as by the assessment circuit, using the determined change in cardiac acceleration information at exertion relative to rest, such as by comparing the determined change or a trend of the determined change to a threshold (e.g., an HFpEF threshold).") and initiating or adjusting a heart failure therapy in response to the detected indicator of HFpEF to HFrEF transition ([0068]: "The IMD 602 can include an assessment circuit configured to detect or determine specific physiologic information of the subject 601, or to determine one or more conditions or provide information or an alert to a user, such as the subject 601 (e.g., a patient), a clinician, or one or more other caregivers. The IMD 602 can alternatively or additionally be configured as a therapeutic device configured to treat one or more medical conditions of the subject 601. The therapy can be delivered to the subject 601 via the lead system and associated electrodes or using one or more other delivery mechanisms.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796